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Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT03473665
Recruitment Status : Terminated (Slow recruitment)
First Posted : March 22, 2018
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Runsheng Wang, MD, MHS, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Ankylosing Spondylitis
Axial Spondyloarthritis
Interventions Drug: Indomethacin
Drug: Diclofenac
Drug: Meloxicam
Drug: Celecoxib
Enrollment 9
Recruitment Details  
Pre-assignment Details This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Arm/Group Title NSAIDs
Hide Arm/Group Description Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title NSAIDs
Hide Arm/Group Description Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Pain   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 9 participants
6
(3 to 8)
[1]
Measure Description: Pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 9 participants
4.9
(1 to 7.65)
[1]
Measure Description: BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Bath Ankylosing Spondylitis Function Index (BASFI)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 9 participants
3.7
(0.4 to 8.4)
[1]
Measure Description: BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
ASAS Endorsed Disease Activity Score (ASDAS)  
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 9 participants
3.34
(2.03 to 4.79)
1.Primary Outcome
Title Change of Pain Score
Hide Description Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame Baseline, Week 4, and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Arm/Group Title NSAIDs x 4 Weeks NSAIDs x 6 Weeks
Hide Arm/Group Description:
NSAIDs x 4 weeks
NSAIDs x 6 weeks
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: units on a scale
-2
(-6 to 2)
-2
(-5 to 0)
2.Secondary Outcome
Title Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Hide Description Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame Baseline, Week 4, and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Arm/Group Title NSAIDs x 4 Weeks NSAIDs x 6 Weeks
Hide Arm/Group Description:
NSAIDs x 4 weeks
NSAIDs x 6 weeks
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: units on a scale
-1.7
(-6.08 to 0.48)
-2.09
(-5.05 to 0.48)
3.Secondary Outcome
Title Change of Bath Ankylosing Spondylitis Function Index (BASFI)
Hide Description Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame Baseline, Week 4, and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Arm/Group Title NSAIDs x 4 Weeks NSAIDs x 6 Weeks
Hide Arm/Group Description:
NSAIDs x 4 weeks
NSAIDs x 6 weeks
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: units on a scale
-0.8
(-5.8 to 1.7)
-1.2
(-4.2 to 0.4)
4.Secondary Outcome
Title Change of ASAS Endorsed Disease Activity Score (ASDAS)
Hide Description Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame Baseline, Week 4, and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Arm/Group Title NSAIDs x 4 Weeks NSAIDs x 6 Weeks
Hide Arm/Group Description:
NSAIDs x 4 weeks
NSAIDs x 6 weeks
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: units on a scale
-0.37
(-1.44 to 0.29)
-0.84
(-1.58 to -0.01)
5.Secondary Outcome
Title Patient Global Assessment of Response to Therapy (PGART)
Hide Description Likert Scale on whether effective or not.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Arm/Group Title NSAIDs x 6 Weeks
Hide Arm/Group Description:
NSAIDs x 6 weeks
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly Disagree
0
   0.0%
Somewhat Disagree
0
   0.0%
Neutral
2
  22.2%
Somewhat Agree
3
  33.3%
Strongly Agree
4
  44.4%
Time Frame 6 weeks
Adverse Event Reporting Description The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
 
Arm/Group Title Celecoxib Meloxicam Indomethacin Diclofenac
Hide Arm/Group Description Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
All-Cause Mortality
Celecoxib Meloxicam Indomethacin Diclofenac
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Celecoxib Meloxicam Indomethacin Diclofenac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib Meloxicam Indomethacin Diclofenac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/2 (50.00%)      2/2 (100.00%)      1/2 (50.00%)    
Gastrointestinal disorders         
diarrhea *  1/3 (33.33%)  1 1/2 (50.00%)  1 1/2 (50.00%)  1 0/2 (0.00%)  0
constipation *  0/3 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Nervous system disorders         
dizziness *  1/3 (33.33%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Headache *  0/3 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders         
hematuria *  0/3 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Shortness of Breath *  0/3 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Runsheng Wang
Organization: Columbia University
Phone: 212-305-4308
EMail: rw2646@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Runsheng Wang, MD, MHS, Columbia University
ClinicalTrials.gov Identifier: NCT03473665    
Other Study ID Numbers: AAAR3505
First Submitted: March 13, 2018
First Posted: March 22, 2018
Results First Submitted: July 15, 2020
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020